Recall Z-1433-2012
Siemens Healthcare Diagnostics, Inc. · initiated February 17, 2012
Product
Dimension Vista(R) MG Flex(R) Reagent Cartridge The Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista(R) System
Codes / lots: Lot numbers 11263AC, 11286AB, 11306BA, 11332AB, 11332AC and 12010AB.
Reason for recall
Firm has confirmed a negative shift of approximately 0.2mg/dL [0.08 mmol/L] in patient and QC samples when using Vista Magnesium
FDA-determined cause: Nonconforming Material/Component
Action taken
Siemens sent an Urgent Field Safety Notification letter dated February 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter explained the correction needed and instructed customers to forward the letter to anyone they may have distributed the affected product. For questions or concerns call 800-441--9250. For questions regarding this recall call 301-631-6299.
Details
- Recall number
- Z-1433-2012
- Initiated
- February 17, 2012
- Posted by FDA
- April 17, 2012
- Terminated
- March 10, 2015
- Product code
- JGJ – Photometric Method, Magnesium
- Quantity
- 9,178
- Distribution
- Nationwide Distribution including Puerto Rico and within the US to Washington, DC and the following States: AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE